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1269667

Outlook Group, LLC — FEI 1000116132

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 15, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Neenah, WI (United States)

Facility

Other inspections at this facility

  • 1145121 (NAI Mon Jun 28 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015315 (NAI Wed Jun 14 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 713272 (NAI Fri Mar 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures